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DRUG:

GLPG5201

i
Other names: GLPG5201, 5201, BCN-CP01, BCNCP01, BCN CP01, GLPG-5201, GLPG 5201, '5201
Associations
Trials
Company:
Galapagos
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
Associations
Trials
1year
Seven-Day Vein-to-Vein Point-of-Care Manufactured CD19 CAR T Cells (GLPG5201) in Relapsed/Refractory CLL/SLL Including Richter's Transformation: Results from the Phase 1 Euplagia-1 Trial (ASH 2023)
GLPG5201, an anti-CD19/41BB CAR-T therapy, is administered as a fresh product following fludarabine/cyclophosphamide lymphodepleting chemotherapy. Upon screening, pts receive daily ibrutinib until leukapheresis...Median prior lines of therapy were 4 (range 2–10); 10/12 pts received a BTK inhibitor, 9/12 pts venetoclax, and 1 pt an allogeneic stem-cell transplant. Five of 7 pts with RT relapsed after, or were refractory to, R-CHOP...GLPG5201 demonstrates rapid in vivo expansion and durable persistence post-infusion. Euplagia-1 is ongoing, and updated data will be presented.
P1 data • CAR T-Cell Therapy • IO biomarker
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TP53 (Tumor protein P53) • CD8 (cluster of differentiation 8) • IGH (Immunoglobulin Heavy Locus) • CD4 (CD4 Molecule)
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TP53 mutation
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Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • cyclophosphamide • fludarabine IV • GLPG5201
over1year
INITIAL CLINICAL RESULTS OF EUPLAGIA-1, A PHASE 1/2 TRIAL OF POINT-OF-CARE MANUFACTURED GLPG5201 IN R/R CLL/SLL WITH OR WITHOUT RICHTER'S TRANSFORMATION (EHA 2023)
Following screening and enrollment, pts will receive daily ibrutinib continuously until mononuclear cell leukapheresis. During GLPG5201 manufacturing, pts receive cyclophosphamide (300 mg/m 2 /day)/fludarabine (30 mg/m 2 /day) for 3 days...GLPG5201 is a new CAR-T therapeutic option for pts with R/R CLL with or without RT, showing limited toxicity and promising efficacy based on current results (n=7). For all 7 pts, GLPG5201 was successfully manufactured at the PoC and administered as a fresh product, with a median vein-to-vein time of 7 days. Rapid complete responses have been observed with a 100% ORR in a heavily pre-treated pt population.
Clinical • P1/2 data
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Imbruvica (ibrutinib) • cyclophosphamide • fludarabine IV • GLPG5201